Johnson & Johnson Careers
Senior Manager Statistical Programming Principal Analyst
Beerse, Belgium; Leiden, Netherlands
Requisition ID: 1805692355W
The Principal Analyst (Senior Manager) within IDAR is an individual contributor and an experienced member of the Statistical Programming and Analysis functional area with proven technical/analytical abilities and expertise in a given therapeutic area.
This position may combine the roles of a programming team leader (Programming/Project Lead) who plans and provides oversight of statistical programming activities (e.g., development, verification and documentation) in support of clinical trial reporting and submissions of high complexity/criticality; and/or that of a technical/scientific leader who develops technical solutions and or disease area/therapeutic area standards resulting in operational effectiveness and efficiencies.
The Principal Analyst (Senior Manager) is expected to have a high level of intra/inter project impact within a TA and is someone who can operate independently requiring minimal guidance..
Coordinates and oversees programming team activities and provides technical and project specific guidance to programming team members to ensure quality and on-time deliverables in compliance with departmental processes. Including outsourced tasks to third party vendors and ensures their performance meets the agreed upon timelines, quality and budget established for the project or study.
Performs comprehensive review of, and provides input into, project requirements and/or project documentation.
Applies strategic decisions and recommendations to develop detailed programming strategy and plans the programming deliverables for projects of high complexity and/or scope.
Designs and develops programs in support of highly complex/critical clinical research analysis and reporting activities, including urgent/on-demand analysis.
Collaborates effectively within statistical programming and with cross-functional working group team members and functional counterparts, including internal and external members.
As scientific/technical leader -
Contributes to the standards strategy for the TA. Accountable for developing disease area standards/owning the content of data life cycle plan (DLP).
Accountable for actively identifying opportunities, evaluating and driving solutions to enhance efficiency. Applies technical and analytical expertise to develop and implement solutions for use on multiple projects, leading to increased efficiency and quality across programming teams.
Partners with key stakeholders (e.g. eBIS group and Clinical Data Standards (CDS) and Analytics Innovation Team (AIT), industry forums to help drive programming efficiency.
Provide technical advice to teams and may work with other disciplines outside department to solve complex problems.
As an experienced member of the functional area -
- Shares knowledge and guides programmers in developing technical and analytical abilities.
Serves as a departmental resource in areas of technical expertise.
May participate in cross-IDAR or cross-functional initiatives/process improvements.
Principal Relationships: Functional contacts within IDAR include but are not limited to, TA Head, IDAR TAL, Statistical Programming Leaders, Programmers, Analytics Innovation Team, Clinical Data Standards (CDS)
Functional contacts Janssen (as collaborator or peer) include but are not limited to Biostatisticians, eBIS
External contacts include but are not limited to, external partners, CRO management and vendor liaisons, industry counterparts and working groups.
Bachelors degree and 6+ yrs relevant experience OR Masters/MBA and 4+ yrs; OR PhD with post-doc experience with 3+ yrs. University/college degree in a scientific discipline is preferred.
In-depth knowledge of statistical programming and industry standard data structures, and thorough understanding of end to end clinical trial process and relevant clinical research concepts. This role requires a working knowledge of regulatory guidelines and publishing processes (e.g. 21 CFR Part 11), basic project management techniques/skills, and team leadership skills.
Demonstrated strong written, verbal communication skills. Ability to manage conflicting demands and priorities and to negotiate successfully. Proven ability to forge strong collaborations with partner functions to have program (e.g. Disease Area/Therapeutic Area level) and/or department level impact.
Demonstrated intellectual curiosity and innovative thinking to shape solutions to allow for optimal design strategies and execution. Recognized expertise in SAS programming and SAS macro code development. Understanding of other SAS products (e.g. SAS/GRAPH, SAS Output Delivery System, etc.). Proven ability to translate complex problems into clear and concise SAS code. Ability to support multiple complex tasks (e.g. adhoc requests).
Preferred Experience Requirements:
Demonstrated ability to manage the outsourcing or externalization of statistical programming work in the clinical trials setting (e.g. Working with CROs, academic institutions). Knowledge of non-SAS programming packages/languages (e.g. Spotfire, S-Plus, R).
Europe/Middle East/Africa-Netherlands-South Holland-Leiden
Janssen Pharmaceutica N.V. (7555)